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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

AIMDS

Of the 345 battery-related reports from January 2013 to October 2015, TGA said in a safety bulletin that active implantable medical devices (AIMDs) are “dominating the battery failure reports.”

The batteries on AIMDs are generally non-rechargeable and replacement would require surgery, TGA notes, though investigations “usually reveal battery depletion is due to excess current drain (low circuit impedances, high output settings and the like) and not generally battery failure.”

Other Failures

In addition to battery problems with AIMDs, there have been reports on the batteries of other devices such as infusion pumps, insulin pumps, patient monitors and vision systems.

The most common kinds of battery failures are for rechargeable batteries that fail to charge, fail to hold a charge or are not inserted correctly.

The US Food and Drug Administration previously conducted a survey on device battery issues and found many of these problems, especially those related to large-volume infusion pumps, may be attributed to staff practices and poor maintenance practices, and not the actual devices.

Recommendations

TGA said users should follow the battery replacement and maintenance recommendations set out by the original equipment manufacturer so that both the device and battery performance will be as expected and certified by the manufacturer.

Health facilities and companies should also establish suitable protocols and procedures to optimize battery management and reduce risks, TGA said, noting other considerations:

Ensure staff are familiar with and follow the manufacturer's instructions